Excessive Cornstarch Powder on Latex (Esmark) Bandages
Hazard [Health Devices Apr 1996;25(4):150]
A member hospital reported finding clumps of
excessive cornstarch on latex (Esmark) bandages. The reporting hospital is concerned that these
clumps, exposed as the bandage is unrolled, may drop onto the operative area.
This disposable product is typically used as a compression bandage to
tightly wrap extremities before surgery, thereby providing a bloodless surgical field.
Like many other latex medical products, the bandages are dusted with cornstarch powder to
prevent the material from adhering to itself while in storage or during use.
Cornstarch, a U.S.P. material, has been used for many years on latex
medical products to make the material easier to work with. It replaced talc powder when
research demonstrated that talc cannot be absorbed by the body and could be a source of
postoperative granulomas. Although cornstarch is sterile and can be absorbed by the body,
some studies have shown that it too has been associated with granulomas in surgical
More recently, with the growing awareness of individuals' allergic
sensitivities to latex in the healthcare workplace, cornstarch has also been recognized as
a vector for transporting latex antigens and inducing allergic reactions when the powder
is aerosolized from latex products.(2) The resulting reactions (e.g., anaphylaxis) can be
While postoperative complications attributable to cornstarch exposure
occur infrequently, and problems of hypersensitivity may be even rarer, both are
preventable. Therefore, efforts should be made to avoid unnecessary exposure to cornstarch
on latex products.
The manufacturer states
that controlling the process of cornstarch application is difficult and that it tries to minimize
powder application while still using enough to prevent the latex from sticking
to itself. It also says that, although powder-free latex bandages can be manufactured, existing
methods may make such products prohibitively expensive for some customers. The company
reports that it is unaware of any industry standards for
acceptable levels of cornstarch on latex medical products.
- Alert staff to the possibility of excessive
cornstarch on latex products, particularly bandages. Have them review
current practices concerning the use of these bandages, specifically their
use near sterile fields or uncovered operative areas.
- If excessive powder on the bandages is likely to
contaminate the operative field, suggest that staff unroll and inspect the
bandages for excessive powder (using sterile technique and keeping the
bandages away from the patient) before wrapping limbs. If clumps are noted,
the bandage should not be applied. (We are unaware of any practical way to
effectively remove excessive powder without compromising the use of the
- Consider the use of alternative products, such as
powder-free latex bandages or nonlatex bandages.
- Sternlieb JJ, McIlrath DC, van Heerden, et al. Starch peritonitis and
its prevention. Arch Surg 1977 Apr;112(4):458-61.
- Breezhold D, Beck W. Surgical glove powders bind latex antigens
Arch Surg 1992
- Bandages, Elastic [10-279]
- Bandages, Pressure [10-284]
Cause of Device-Related Incident
Device factor: Manufacturing error
Mechanism of Injury or Death